SUMMARY/ABSTRACT
HIV is declining in many parts of the world, but rising in Latin America, including Brazil. From 2010 to 2019, the
number of new HIV infections in Latin America increased 21%, compared to a global reduction of 23%. The
number of reported HIV cases in Brazil increased from 13,719 in 2011 to 40,880 in 2021, with increases driven
by sexual and gender minority youth aged 15-24 years (SGM youth). Among men aged 15-24 years, HIV
incidence per 100,000 increased from 37.8 in 2000 to 66.5 in 2018 – a 75% increase. HIV pre-exposure
prophylaxis (PrEP) was approved in Brazil in 2021 for adolescents aged 15-17 years, but PrEP uptake has been
<1% among SGM youth. Our team conducted the first and largest PrEP demonstration study among adolescents
in Latin America (PrEP1519), in which we implemented peer navigation strategies that linked 1174 SGM youth
(20% of 5870 recruited) to PrEP services at SGM-affirming health facilities. In qualitative interviews, SGM youth
articulated positive relationships with peer navigators but reluctance to engage with facility-based services due
to past experiences with stigma and logistical and structural challenges accessing care. These data suggest that
programs featuring peers were welcomed, but alternatives to facility-based services are urgently needed to scale
up PrEP among SGM youth. We hypothesize that equipping peer lay workers – trained SGM youth who are part
of SGM-affirming health care teams – to deliver PrEP to SGM youth in community venues will increase PrEP
uptake among SGM youth. The goal of this project is to conduct a series of studies to refine, test, and understand
experiences with a peer-led community-based intervention (CommunityPrEP, “COMPrEP”). In Aim 1, we will
conduct qualitative interviews guided by the Consolidated Framework for Implementation Research to identify
key modifications for the PrEP1519 peer navigator intervention to adapt it for community delivery by peer lay
workers. In Aim 2, we will randomize 1400 SGM youth to access PrEP through peer lay workers at community
venues (COMPrEP intervention) or health providers at SGM-affirming health facilities (standard care). We will
conduct intent-to-treat analyses with modified Poisson regression to compare PrEP uptake (primary outcome)
across randomized arms. We will follow the subset that initiates PrEP (expected to be N~385) for 12 months to
compare secondary outcomes (1-month adherence, 3-month and 12-month persistence). Throughout the trial,
we will monitor participant safety through our study team and an external monitoring board. In Aim 3, we will use
the RE-AIM framework to explore experiences with the COMPrEP intervention through qualitative interviews with
SGM youth, peer lay workers and health providers, and local and national policymakers to develop next steps.
The proposed work will provide robust evidence about whether PrEP delivery facilitated by peer lay workers in
community settings increases PrEP uptake, adherence, and persistence among SGM youth in Brazil. With
members of the National HIV Program in Brazil as our collaborators, we will be well-positioned to provide results
to guide programming for this population and scale up the intervention if effective.
